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NPRA's own measurement, with the Centre for Innovation in Regulatory Science, of how long Malaysia took to approve new medicines: the median fell from 515 calendar days for those approved in 2017 to 399 for those approved in 2019.
NPRA has worked with the Centre for Innovation in Regulatory Science since 2018 to analyse approval of new active substances and biosimilars. NPRA representatives completed the Optimizing Efficiencies in Regulatory Agencies (OpERA) country report on the review process and registration pathways, and supplied milestone data on 24 new active substances approved in 2019, compared with the 2017 baseline.
This is the only measured approval time for Malaysia that OnCo found, and it covers all new medicines, not cancer medicines alone; it predates the faster reliance routes introduced from 2024.
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